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The Prevalence of Pulmonary Hypertension in Patients With COVID-19.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04459364
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Attgeno AB

Brief Summary:

The virus infection Covid-19 fills our hospitals and intensive care departments in a very unique way and there is a lack of essential insight into the pathophysiology of the disease. As a result, very specific treatment options are missing. The US Medicines Agency (FDA) has in the last days given a general license for treatment with inhaled nitric oxide (iNO). Inhaled NO in Sweden (and Europe) is approved for the indication of pulmonary hypertension in adults.

However, no one has yet described the occurrence of pulmonary hypertension, with or without right ventricular loading, in the Covid-19 patients who become so seriously ill that they need to be treated at an IVA ward. Knowledge of this is, of course, a prerequisite for determining the need for pulmonary artery catheterization (PA catheter, Swan-Ganz catheter) and also to better understand whether iNO treatment or other forms of lung selective vasodilation therapy may be of benefit to this patient group.


Condition or disease
Hypertension, Pulmonary Right Ventricular Overload COVID

Detailed Description:

Demographics and data from study variables will be documented in paper CRFs at the investigational site.

  • Demography

    o Age, sex

  • Covid-19 related variables

    o COVID-19 diagnosis

  • Concomitant diseases

    o Comorbidity, previous and present

  • Cardiovascular risk factors

    o Smoking

  • Laboratory values
  • On-site measurements o Evaluation with echocardiography

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 21 Days
Official Title: The Prevalence of Pulmonary Hypertension, With or Without Right Ventricular Loading, in Patients With COVID-19 Who Are Being Treated With a Respirator in the Intensive Care Unit.
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : July 7, 2020
Estimated Study Completion Date : July 10, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Prevalence [ Time Frame: Day 1 ]
    To determine the prevalence of pulmonary hypertension and right ventricular load in patients with COVID-19 treated in intensive care unit evaluated by routine echocardiography.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This is a non-interventional retrospective study to be performed in an intensive care unit in Sweden. The study will include 80 Covid-19 patients who had been examined with echocardiography. Data will be collected through chart review.
Criteria

Inclusion Criteria:

  • Men and women at least 18 years of age
  • Diagnosed with COVID-19 and is treated at an intensive care unit.

Exclusion Criteria:

  • Responsible investigator considers that co-morbidity is so pronounced that it does not allow reasonable interpretation of data.
  • Missing verified diagnosis of COVID-19

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459364


Contacts
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Contact: Per-Arne Lönnqvist, Professor +46707210650 per-arne.lonnqvist@ki.se

Locations
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Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Per-Arne Lönnqvist, Professor    +46707210650    per-arne.lonnqvist@ki.se   
Sponsors and Collaborators
Attgeno AB
Investigators
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Principal Investigator: Per-Arne Lönnqvist, Professor Karolinska Institutet
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Responsible Party: Attgeno AB
ClinicalTrials.gov Identifier: NCT04459364    
Other Study ID Numbers: 20200422PA
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participants data that underlie the results reported in this article will be shared, after deidentification (text, figures and appendices)
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria: Researchers who provide a methodologically sound proposal and to achieve aims in the proposal. Proposals should be directed to per-arne.lonnqvist@ki.se. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases